Delivery device for prosthetic heart valve with capsule adjustment device

ABSTRACT

A delivery device for percutaneously delivering a stented prosthetic heart includes a sheath, a handle, and adjustment device including a fine adjustment mechanism, and an outer stability shaft. The sheath defines a lumen and is configured to compressively constrain the stented prosthetic heart valve. The handle is coupled to the proximal portion of the sheath and includes an actuator mechanism coupled to a proximal portion of the sheath that is configured to selectively move the sheath relative to the housing to release the stented prosthetic heat valve. The adjustment device is coupled to the handle and includes an adjustment lumen through which the sheath and the handle slidably extend. The outer stability shaft is coupled to the adjustment device. The fine adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft.

FIELD OF THE INVENTION

The present invention relates to systems and methods for percutaneousimplantation of a prosthetic heart valve. More particularly, it relatesto the systems and methods for the fine adjustment and placement of astented prosthetic heart valve via transcatheter implantation.

BACKGROUND

Heart valves are sometimes damaged by disease or by aging, resulting inproblems with the proper functioning of the valve. Heart valvereplacement has become a routine surgical procedure for patientssuffering from valve dysfunctions. Traditional open surgery inflictssignificant patient trauma and discomfort, requires extensiverecuperation times, and may result in life-threatening complications.

To address these concerns, efforts have been made to perform cardiacvalve replacements using minimally-invasive techniques. In thesemethods, laparoscopic instruments are employed to make small openingsthrough the patient's ribs to provide access to the heart. Whileconsiderable effort has been devoted to such techniques, widespreadacceptance has been limited by the clinician's ability to access onlycertain regions of the heart using laparoscopic instruments.

Still other efforts have been focused upon percutaneous transcatheter(or transluminal) delivery of replacement cardiac valves to solve theproblems presented by traditional open surgery and minimally-invasivesurgical methods. In such methods, a valve prosthesis is compacted fordelivery in a catheter and then advanced, for example through an openingin the femoral artery, and through the descending aorta to the heart,where the prosthesis is then deployed in the valve annulus (e.g., theaortic valve annulus).

Various types and configurations of prosthetic heart valves areavailable for percutaneous valve replacement procedures. In general,prosthetic heart valve designs attempt to replicate the function of thevalve being replaced and thus will include valve leaflet-likestructures. Valve prostheses are generally formed by attaching abioprosthetic valve to a frame made of a wire or a network of wires.Such a valve prosthesis can be contracted radially to introduce thevalve prosthesis into the body of the patient percutaneously through acatheter. The valve prosthesis can be deployed by radially expanding itonce positioned at the desired target site.

In addition to the delivery device itself, typical transcatheter heartimplantation techniques entail the use of a separate introducer deviceto establish a portal to the patient's vasculature (e.g., femoralartery) and through which the prosthetic valve-loaded delivery device isinserted. The introducer device generally includes a relatively shortsheath and a valve structure. By inserting the prosthetic heartvalve-loaded sheath through the introducer valve and sheath, a lowfriction hemostasis seal is created around the outer surface of thedelivery sheath. While highly desirable, friction between the introducerdevice and the delivery sheath can be problematic, leading to unexpectedmovement of the prosthesis prior to release from the delivery device. Ifthe deployed prosthesis is incorrectly positioned relative to the nativeannulus, serious complication may arise including paravalvular leakage(PVL) or the requirement for placement of a permanent pacemaker.

For example, FIG. 1A illustrates, in simplified form, an introducerdevice 10 establishing a portal to a patient's vasculature 12, andthrough which a prosthetic heart valve-loaded delivery shaft 14 has beeninserted. As shown, delivery shaft 14 has been manipulated to locate theloaded prosthetic heart valve 16 (generally referenced) near a desiredposition relative to an aortic valve 18. An outer delivery sheath 20contains the prosthetic heart valve 16. However, it is not alwayspossible to accurately position the delivery device containing theprosthetic heart valve 16 at the desired position. Accordingly,adjustments in the position must be made. Conventionally, adjusting theposition of the prosthetic heart valve 16 is accomplished by movinghandle 22 proximally or distally. In the example of FIG. 1B, handle 22is moved proximally. However, as handle 22 is moved proximally, outerdelivery sheath 20 pulls towards the inner wall of the descending aorta29 and away from outer wall of aortic arch 28. With this movement,handle 22 has moved, but prosthetic heart valve 16 has not movedrelative to aortic valve 18. Thus, it takes more movement of handle 22to move prosthetic heart valve 22. Further, the location of prostheticheart valve 16 often needs to be adjusted a very small amount, which isdifficult to accomplish by pushing or pulling handle 22.

Accordingly, there is a need for an improved adjustment mechanism andmethod to more accurately position a prosthetic heart valve implantedvia transcatheter delivery devices and methods.

SUMMARY OF THE INVENTION

Embodiments hereof relate to a delivery device for percutaneouslydelivering a stented prosthetic heart valve to the site of a damaged ordiseased native valve. The stented prosthetic heart valve is radiallyexpandable from a radially compressed configuration to a radiallyexpanded configuration. The delivery device includes a sheath, a handle,and adjustment device including a fine adjustment mechanism, and anouter stability shaft. The sheath defines a lumen and is configured tocompressively constrain the stented prosthetic heart valve. The handleis coupled to the proximal portion of the sheath and includes anactuator mechanism coupled to a proximal portion of the sheath that isconfigured to selectively move the sheath relative to the housing torelease the stented prosthetic heat valve. The adjustment device iscoupled to the handle and includes an adjustment lumen through which thesheath and the handle slidably extend. The outer stability shaft iscoupled to the adjustment device. The fine adjustment mechanism isconfigured to selectively move the handle and the sheath relative to theadjustment device and the outer stability shaft.

Embodiments hereof also relate to a method for restoring a defectiveheart valve in a patient. The method includes manipulating a deliverydevice to guide a prosthetic heart valve through a patient's vasculatureand into the defective heart valve by moving a handle of the deliverydevice. The delivery device is loaded with a prosthetic heart valve in aradially compressed configuration, the prosthetic heart including astent frame to which a valve structure is attached. The delivery deviceincludes a delivery sheath, an outer stability shaft, a handle, and anadjustment device. The sheath constrains the prosthetic heart valve inthe radially compressed configuration. The outer stability shaft iscoaxially received over the delivery sheath and terminates proximal ofthe prosthetic heart valve when the delivery device is in the deliveryconfiguration. The handle includes a housing and an actuating mechanismcoupled to the delivery sheath. The adjustment device is coupled to thehandle. Moving the handle causes the adjustment device, delivery sheath,and the outer stability shaft to move. The location of the prostheticheart valve within the defective heart valve is finely adjusted bymanipulating the fine adjustment mechanism of the adjustment device.Manipulating the fine adjustment mechanism causes the handle and thedelivery sheath to move relative to the adjustment device and the outerstability shaft. The delivery sheath is withdrawn from the prostheticheart valve by actuating the actuator mechanism such that the deliverysheath slides relative to the outer stability shaft and the handle torelease the prosthetic heart valve from the delivery sheath. With therelease of the prosthetic heart valve from the delivery sheath, theprosthetic heart valve self-expands into engagement with the nativeheart valve.

BRIEF DESCRIPTION OF DRAWINGS

FIGS. 1A-1B are simplified illustrations of conventional transcatheterdelivery of a stented prosthetic heart valve.

FIG. 2A is a side illustration of a stented prosthetic heart valveuseful with systems, devices, and methods of the present disclosure andin a normal, expanded configuration.

FIG. 2B is a side illustration of the prosthetic heart valve of FIG. 2Ain a radially compressed configuration.

FIG. 3 is a side illustration of the delivery device of the presentdisclosure.

FIG. 4 is a cutaway illustration of an adjustment device of the deliverydevice of FIG. 3.

FIG. 5 is an exploded perspective illustration of the delivery device ofFIG. 3.

FIG. 6 is a cutaway illustration of the delivery device of FIG. 3.

FIGS. 7A-7E are illustrations of the adjustment of the location of acapsule of the delivery device of FIG. 3.

FIGS. 8A-8B are simplified illustrations of a method of adjusting thelocation of a stented prosthetic heart valve during transcatheterdelivery using the delivery device of FIG. 3.

DETAILED DESCRIPTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal”, when used in the following description to refer to acatheter or delivery device, are with respect to a position or directionrelative to the treating clinician. Thus, “distal” and “distally” referto positions distant from, or in a direction away from, the clinicianand “proximal” and “proximally” refer to positions near, or in adirection toward, the clinician.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Furthermore, there is no intention to be bound by anyexpressed or implied theory presented in the preceding technical field,background, brief summary, or the following detailed description.

As referred to herein, the stented prosthetic heart valves used inaccordance with and/or as part of the various systems, devices, andmethods of the present disclosure may include a wide variety ofdifferent configurations, such as a bioprosthetic heart valve havingtissue leaflets or a synthetic heart valve having polymeric, metallic,or tissue-engineered leaflets, and can be specifically configured forreplacing any heart valve.

In general terms, the stented prosthetic heart valve of the presentdisclosure includes a stent supporting a valve structure (tissue orsynthetic), with the stent having a normal, expanded configuration thatis collapsible to a compressed configuration for loading within adelivery device. The stent is usually constructed to self-deploy orexpand when released from the delivery device. For example, the stentedprosthetic heart valve useful with the present disclosure can be aprosthetic heart valve sold under the trade name CoreValve® availablefrom Medtronic CoreValve, LLC. Other non-limiting examples of thetranscatheter heart valve prostheses useful with the systems, devices,and methods of the present disclosure are described in U.S. Pat. Nos.7,662,186; and 7,740,655, which are incorporated in their entirety byreference herein. The stents or stent frames are support structures thatcomprise a number of struts or wire portions arranged relative to eachother to provide a desired compressibility and strength to theprosthetic heart valve. In general terms, the stents or stent frames ofthe present disclosure are generally tubular support structures havingan internal area in which valve structure leaflets will be secured.

With the above understanding in mind, one non-limiting example of astented prosthetic heart valve 30 useful with systems, devices, andmethods of the present disclosure is illustrated in FIG. 2A. As a pointof reference, the prosthetic heart valve 30 is shown in a normal,pre-set, or expanded configuration in the view of FIG. 2A. FIG. 2Billustrates the prosthetic heart valve 30 in a compressed configuration(e.g., when compressively retained within an outer catheter or sheath).Prosthetic heart valve 30 includes a stent, or stent frame 32, and avalve structure 34. The valve structure 34 is assembled to stent frame32 and provides two or more (typically three) leaflets 36. Stent frame32 may assume differing forms and construction based upon applicationneeds as described in greater detail in U.S. Pat. No. 8,579,963, whichis incorporated in its entirety by reference herein.

With the above understanding of the stented prosthetic heart valve 30 inmind, one embodiment of a delivery device 100, in accordance with thepresent disclosure, for percutaneously delivering and implanting aprosthetic heart valve 30, is shown in FIG. 3. Delivery device 100 mayassume differing forms and construction based upon application needs asdescribed in greater detail in U.S. Pat. Nos. 8,579,963; 8,491,650; and8,465,541, which are incorporated in their entirety by reference herein.

Delivery device 100 includes a handle 180, an adjustment device 150, anouter stability shaft 110, a delivery sheath assembly 102, and an innershaft assembly 104 as shown in FIG. 3. Each of these components isdescribed in greater detail below. Delivery device 100 is configured tobe used for transcatheter valve implantation. Other embodiments of thedelivery device and adjustment device are possible. Delivery device 100,described in greater detail below, is merely an exemplary embodiment ofa transcatheter delivery device and modifications can be made to theembodiments described herein without departing from the spirit and scopeof the present invention. Therefore, the following detailed descriptionis not meant to be limiting. Further, the systems and functionsdescribed below can be implemented in many different embodiments ofhardware. Any actual hardware described is not meant to be limiting. Theoperation and behavior of the systems and methods presented aredescribed with the understanding that modifications and variations ofthe embodiments are possible given the level of detail presented.

Components in accordance with the embodiment of delivery device 100 ofFIG. 3 are presented in greater detail in FIGS. 4-6. Various features ofthe components of delivery device 100 reflected in FIGS. 4-6 anddescribed below can be modified or replaced with differing structuresand/or mechanisms. The present disclosure is in no way limited todelivery sheath assembly 102, inner shaft assembly 104, outer stabilityshaft 110, adjustment device 150, and handle 180 shown and describedbelow. In more general terms, delivery devices in accordance with theprinciples of the present disclosure provide features capable ofcompressively retaining a self-expanding, stented prosthetic heart valve(e.g., the capsule 108), along with an mechanism and method for finelyadjusting the position of a self-expanding, stented prosthetic heartvalve (e.g., adjustment device 150) within a defective heart valve.

In the embodiment of FIGS. 4-6, delivery sheath assembly or sheath 102includes a capsule 108 and a shaft 118, and defines a lumen 112extending from a proximal end 130 to a distal end 132 of delivery sheathassembly 102. The length and thickness of capsule 108 are determined bythe requirements of the specific application and are described ingreater detail in U.S. Pat. No. 8,579,963, previously incorporated byreference herein. Shaft 118 is configured for fixed connection tocapsule 108 at connection point 116, and extends proximally from capsule108, with shaft 118 configured for fixed connection of delivery sheathassembly 102 to handle 180. Although delivery sheath assembly 102 isdescribed herein as including capsule 108 and shaft 118, capsule 108 maysimply be an extension of shaft 118 and the delivery sheath assembly 102may be described simply as sheath 102.

Inner shaft assembly 104 can assume a variety of configurationsdescribed in greater detail in U.S. Pat. No. 8,579,963, previouslyincorporated by reference herein. In general, inner shaft assembly 104includes a proximal inner shaft 114, a retention member 120, and a tip121. Proximal inner shaft 114 connects to retention member 120, andretention member 120 connects to tip 121. Proximal inner shaft 114 isconfigured for fixed connection of inner shaft assembly 104 to handle180. The components of inner shaft assembly 104 combine to define acontinuous lumen 122, which is sized to receive an auxiliary componentsuch as a guide wire (not shown). Although inner shaft assembly 104 isdescribed herein as including proximal inner shaft 114, retention member120, and tip 121, retention member 120 and tip 121 may simply be anextension of proximal inner shaft 114 and the inner shaft assembly 104may be described simply as inner shaft 104.

Outer stability shaft 110 can assume a variety of configurationsdescribed in greater detail in U.S. Pat. No. 8,579,963, previouslyincorporated by reference herein. In general, outer stability shaft 110is configured for fixed connection to adjustment device 150. Outerstability shaft 110 serves as a stability shaft for delivery device 100,and has a proximal end 124, a distal end 126, and a passageway 128extending between ends 124 and 126. The passageway is sized to coaxiallyreceive delivery sheath assembly 102, and in particular shaft 118, in amanner permitting the sliding of shaft 118 relative to outer stabilityshaft 110.

Handle 180 can assume a variety of configurations described in greaterdetail in U.S. Pat. No. 8,579,963, previously incorporated by reference,and modified herein. In general, handle 180 includes a housing 182, anactuator mechanism 184, a handle extension 186, and teeth 188 on handleextension 186. Housing 182 retains actuator mechanism 184. Sheath 102 iscoupled to actuator mechanism 184 such that movement of actuatormechanism 182 causes sheath 102 to move relative to outer stabilityshaft 110 and inner shaft assembly 104, as described below. Handleextension 186 extends from the distal end of housing 182.

In the embodiment of FIGS. 5-6, handle 180 provides a surface forconvenient handling and grasping by a user, and can have a generallycylindrical shape as shown. While the handle of FIGS. 5-6 is shown witha cylindrical shape, it is not meant to limit the design, and othershapes and sizes are contemplated based on application requirements.

Handle 180 is configured to maintain portions of the actuator mechanism184 within a cavity 183 defined by housing 182. In the embodiment shownin FIGS. 5-6, housing 180 further forms a longitudinal slot 185 throughwhich actuator mechanism 184 extends for interfacing by a user. Handleextension 186 extends distally from housing 182 and provides a mountingsurface for teeth 188. For example, and not by way of limitation, teeth188 may be formed integrally as part of handle extension 186 or may becoupled to handle extension 186 by adhesives, welding, clamping, andother coupling devices as appropriate. While FIGS. 5-6 show teeth 188located on one side of handle extension 186, this is not meant to limitthe design, and teeth 188 may be located elsewhere on handle extension186.

Adjustment device 150, as shown in the embodiment of FIGS. 4-6, includesan adjustment housing 151, an adjustment mechanism 152, and an extension160 at the distal end of adjustment device 150. The components ofadjustment device 150 combine to define a continuous lumen 159 throughadjustment device 150. The proximal portion of lumen 159 is configuredto accept handle extension 186 of handle 180. A distal portion of lumen159 defined by extension 160 is configured to accept the proximal end ofouter stability shaft 110. Outer stability shaft 110 may be coupled toextension 160 by adhesives, welding, clamping, and other couplingdevices, as appropriate.

Adjustment device 150 provides a surface for convenient handling andgrasping by a user, and can have a generally cylindrical shape as shown.While adjustment device 150 of FIGS. 4-6 is shown with a cylindricalshape, it is not meant to limit the design, and other shapes and sizesare contemplated based on application requirements. Adjustment device150 is configured to maintain portions of adjustment mechanism 152within a cavity defined by housing 151. In the embodiment shown in FIG.5, housing 151 further includes a longitudinal slot 161 through whichadjustment mechanism 152 extends for interfacing by a user.

Adjustment mechanism 152 includes a first toothed wheel 154 and a secondtoothed wheel 158, as shown in FIGS. 4-6. First toothed wheel 154 hasteeth 153. Second toothed wheel 158 has teeth 156. First toothed wheel154 is disposed within housing 151 on a first pivot axis 155 such thatfirst toothed wheel 154 rotates about first pivot axis 155. The upperradius of first toothed wheel 154 extends through longitudinal slot 161in housing 151 for user interface. Second toothed wheel 158 is disposedwithin housing 151 on a second pivot axis 157 such that second toothedwheel 158 rotates about second pivot axis 157. Teeth 156 on secondtoothed wheel 158 are configured to engage with teeth 188 on handleextension 186, as described in more detail below. First toothed wheel154 and second toothed wheel 158 are configured such that teeth 153 offirst toothed wheel 154 engage with teeth 156 of second toothed wheel158. While FIGS. 4-6 show adjustment mechanism 152 having a specificnumber of teeth 153 on first toothed wheel 154 and a specific number ofteeth 156 on second toothed wheel 158, this is not meant to limit thedesign and the number of teeth 153 and 156 may assume otherconfigurations.

Adjustment mechanism 152 is generally constructed to provide selectiveretraction/advancement of handle 180, delivery sheath assembly 102, andinner shaft assembly 104 relative to housing 151 of adjustment device150 and outer stability shaft 110. Adjustment mechanism 152 can have avariety of constructions and/or devices capable of providing the desireduser interface and the current embodiment shown in FIGS. 4-6 is notmeant to limit the design, but rather provide an example of one possibleembodiment. For example, other embodiments of adjustment device 152 mayutilize only first toothed wheel 152 to engage teeth 188 on handleextension 186.

When delivery device 100 is assembled, handle extension 186 resideswithin the proximal portion of lumen 159 of adjustment device 150, andis configured such that teeth 188 on handle extension 186 engage teeth156 of second toothed wheel 158 of adjustment device 150. Handleextension 186 is sized such that it may fit within lumen 159 ofadjustment device 150 and retract/advance within lumen 159 with useractuation of adjustment mechanism 152 of adjustment device 150.

Actuator mechanism 184 is generally constructed to provide selectiveretraction/advancement of the delivery sheath assembly 102 and can havea variety of constructions and/or devices capable of providing thedesired user interface. One example of an actuator mechanism 184 isfurther described in U.S. Pat. No. 8,579,963, previously incorporated byreference herein.

Construction of delivery device 100 is reflected in FIGS. 5-6 andincludes delivery sheath assembly 102 being coaxially and slidablydisposed between inner shaft assembly 104 and outer stability shaft 110.FIG. 6 shows delivery device 100 in the delivery configuration, with aprosthetic heart valve in a radially compressed configuration loadedwithin capsule 108. As shown in FIG. 6, capsule 108 is coaxiallydisposed over retention member 120 of inner shaft assembly 104. Innershaft assembly 104 is rigidly connected to housing 182. Delivery sheathassembly 102 is movably connected to housing 182 via actuator mechanism184. Outer stability shaft 110 is rigidly connected to adjustment device150, as described previously. Generally speaking, delivery sheathassembly 102 can be retracted in a proximal direction relative to innershaft assembly 104, outer stability shaft 110, and housing 182 from thedelivery configuration of FIG. 6 to a deployed configuration whereincapsule 108 is retracted proximally such that capsule 108 does notsurround the prosthetic heart valve. This allows the prosthetic heartvalve to radially expand for engagement with the native heart valve (notshown).

Inner shaft assembly 104 extends within lumen 112 of sheath 102.Proximal inner shaft 114 of inner shaft assembly 104 extends proximallythrough lumen 159 of adjustment device 150, continuing proximallythrough housing 182, and is rigidly connected to handle 180 such thatlumen 122 provides access for auxiliary components (e.g., a guide wire)therein. Proximal inner shaft 114 may be coupled to handle 180, forexample, and not by way of limitation, by adhesives, welding, clamping,and other coupling devices as appropriate. Inner shaft assembly 104 isfixed relative to handle 180.

Delivery sheath assembly 102 extends within passageway 128 of outerstability shaft 110. Shaft 118 of delivery sheath assembly 102 extendsproximally through lumen 159 of adjustment device 150, continuingproximally into housing 182 of handle 180, and is rigidly connected toactuator mechanism 184 of handle 180. Shaft 118 may be coupled toactuator mechanism 184 by adhesives, welding, clamping, and othercoupling devices as appropriate. Delivery sheath assembly 102 is movablerelative to handle 180 and adjustment device 150 by actuator mechanism184. However, if actuator mechanism 184 is not moved and handle 180 ismoved, delivery sheath assembly 102 moves with handle 180, not relativeto handle 180, as explained in more detail below.

Outer stability shaft 110 is disposed within distal portion of lumen 159and is coupled to extension 160. For example, and not by way oflimitation, outer stability shaft 110 may be coupled to extension 160 byadhesives, welding, clamping, and other coupling devices as appropriate.Although outer stability shaft 110 is described as being attached toextension 160, outer stability shaft 110 may be coupled to housing 151of adjustment device 150, and extension 160 may be excluded. Outerstability shaft 110 extends distally from adjustment device 150, andencompasses a portion of the length of shaft 118, thus stabilizing atleast a portion of shaft 118 without impeding sliding/transitioning ofcapsule 108 from the delivery configuration to the deployedconfiguration. Outer stability shaft 110 is fixed longitudinallyrelative to adjustment device 150.

With the above understanding of components in mind, operation andinteraction of components of the present disclosure may be explained.FIG. 4 illustrates adjustment device 150. Adjustment mechanism 152 ofadjustment device 150 is configured such that, as first toothed wheel154 is rotated in a first direction, teeth 153 on first toothed wheel154 engage with teeth 156 on second toothed wheel 158 such that rotationof first toothed wheel 154 causes rotation of second toothed wheel 158in a second direction opposite the first direction. Teeth 156 of secondtoothed wheel 158 engage teeth 188 on handle extension 186 such thathandle extension 186, and thus handle 180, moves relative to housing 151of adjustment device 150. Inner shaft assembly 104 and delivery sheathassembly 102, being coupled to handle 180, also move relative to housing151 of adjustment device 150. The engagement of teeth 156 on secondtoothed wheel 158 with teeth 188 on handle extension 186 also translatesthe rotational movement of second toothed wheel 158 to longitudinalmovement of handle extension 186.

Handle 180 resides partially within the proximal end of adjustment lumen159 of adjustment housing 151 such that teeth 188 on handle extension186 are oriented parallel to longitudinal axis LA of adjustment device150. First toothed wheel 154 and second toothed wheel 158 are orientedrelative to longitudinal axis LA such that rotation of first toothedwheel 154 is parallel to longitudinal axis LA (i.e., first pivot axis155 is transverse to longitudinal axis LA). In the embodiment shown,second toothed wheel 158 is also oriented relative to longitudinal axisLA such that rotation of second toothed wheel 158 is parallel tolongitudinal axis LA (i.e., second pivot axis 157 is transverse tolongitudinal axis LA). Adjustment mechanism 154 is configured toselectively move handle 180, delivery sheath assembly 102, and innershaft assembly 104 relative to housing 151 of adjustment device 150 andouter stability shaft 110 a distance in the range of 1-50 mm, preferablyin the range of 10-40 mm, and most preferably in the range of 20-30 mm.up to 25.0 mm.

FIGS. 7A-7E schematically show delivery device 100 in operation. InFIGS. 7A-7E the exposed portion of first toothed wheel 154 is rotated ina first direction 200, towards the distal end of adjustment device 150.Adjustment mechanism 152 is configured such that, as toothed wheel 154is rotated in first direction 200, teeth 153 on first toothed wheel 154engage teeth 156 on second toothed wheel 158 to rotate second toothedwheel 158 in direction 202. Teeth 156 of second toothed wheel 158 engageteeth 188 on handle extension 186 such that handle extension 186, andthus handle 180, move in distal direction 204, while housing 151 ofadjustment device 150 remains stationary. Delivery sheath assembly 102and inner shaft assembly 104, being coupled to handle 180, also move indistal direction 204. Although FIGS. 7A-7E only show movement of firsttoothed wheel 154 in first direction 200, resulting movement of handle180, inner shaft assembly 104, and delivery sheath assembly 102 indistal direction 204, movement of first toothed wheel 154 in seconddirection 202 results in movement of second toothed wheel 158 in firstdirection 200, and movement of handle 180, inner shaft assembly 104, anddelivery sheath assembly 102 in a proximal direction opposite distaldirection 204. Movement direction, either distally or proximally, ofhandle 180, delivery sheath assembly 102, and inner shaft assembly 104,relative to housing 151 of adjustment device 150 is dependent upon thedirection of rotation of first toothed wheel 154. Rotational directionof first toothed wheel 154 is selected by operator manipulation.

In some embodiments, delivery device 100 can be used in conjunction withan introducer device 10 as shown in FIGS. 8A-8B. Introducer devicesgenerally include an introducer sheath 13 and a valve 11. The introducersheath 13 is typically a resilient body. To access a bodily lumen (e.g.,femoral artery) of the patient, an incision is formed in the patient'sskin, and introducer sheath 13 inserted through the incision and intothe desired bodily lumen. Valve 11 fluidly closes the connection withthe bodily lumen external the patient. Delivery device 100 is theninserted into the bodily lumen via introducer device 10.

As generally reflected in FIG. 8A, introducer sheath 13 has an innerdiameter greater than outer stability shaft 110 (as well as capsule108), such that capsule 108 can readily be delivered through the bodilylumen, directed to other branches of the patient's vasculature 12, andthen into the defective heart valve implantation site 18 (e.g., aorticheart valve). In this regard, introducer valve 11 frictionally contactsouter stability shaft 110, thereby establishing a low frictionhemostasis seal around outer stability shaft 110. Outer stability shaft110 isolates delivery sheath assembly 102 from introducer sheath 13 andvalve 11. While outer stability shaft 110 is in physical contact withportions of introducer device 10, the delivery sheath assembly 102 doesnot directly contact introducer device 10. Further, outer stabilityshaft 110 overtly supports shaft 118 in traversing the tortuousvasculature, minimizing occurrences of kinks forming in shaft 118 when,for example, moving across the aortic arch 28.

Once the prosthetic heart valve 30 is positioned near the deploymentsite, as shown in FIG. 8A, the position of capsule 108 and retentionmember 120 may be finely adjusted to the desired location within thenative heart valve 18 via user manipulation of adjustment mechanism 152.Because outer stability shaft 110 is not moved when adjustment mechanism152 is manipulated, outer stability shaft 110 does not move within theaorta as described with respect to FIGS. 1A and 1B. Thus, movement ofhandle 180 by adjustment mechanism 152 is directly translated tomovement of capsule 108 and retention member 120, with the prostheticheart valve disposed within capsule 108. Determination of optimaldeployment location is based upon known methods such as, but not limitedto sonography and radioopaque markers. As shown in FIG. 8A, capsule 108has been roughly positioned proximally of native aortic valve 18, but isnot in the desired implantation location.

Thus, a user interface for adjustment mechanism 152 of adjustment device150 is manipulated by the user to manipulate capsule 108 to the desireddeployment location. For the delivery device of the embodiment of FIG.7, first toothed wheel 154 of adjustment mechanism 152 is rotated indirection 200, towards the distal end of adjustment device 150, suchthat handle 180, delivery sheath assembly 102 (including capsule 108),and inner shaft assembly 104 advance incrementally towards the desireddeployment location, as shown in FIG. 8B. The movement of handle 180,delivery sheath assembly 102 (including capsule 108), and inner shaftassembly 104 is relative to adjustment device 150 and outer stabilityshaft 110, as described above.

To deploy prosthetic heart valve 16 from delivery device 100 at thedesired deployment location, actuator mechanism 184 of handle 180 isoperated proximally to retract delivery sheath assembly 102. Inparticular, shaft 118 and capsule 108 are moved proximally to withdrawcapsule 108 from its position surrounding prosthetic heart valve 30,thereby permitting prosthetic heart valve 30 to self-deploy fromdelivery device 100.

While only some embodiments have been described herein, it should beunderstood that it has been presented by way of illustration and exampleonly, and not limitation. Various changes in form and detail can be madetherein without departing from the spirit and scope of the invention,and each feature of the embodiment discussed herein, and of eachreference cited herein, can be used in combination with the features ofany other embodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

What is claimed is:
 1. A delivery device for percutaneously delivering astented prosthetic heart valve, the stented prosthetic heart valve beingradially expandable from a radially compressed configuration to aradially expanded configuration, the delivery device comprising: asheath defining a lumen, wherein the sheath is configured tocompressively constrain the stented prosthetic heart valve; a handleincluding a housing and an actuator mechanism, wherein the actuatormechanism is coupled to a proximal portion of the sheath and isconfigured to selectively move the sheath relative to the housing torelease the stented prosthetic heart valve; an adjustment device coupledto the handle, wherein the adjustment device includes an adjustmentlumen through which the sheath and the handle slidably extend, whereinthe adjustment device includes a fine adjustment mechanism; and an outerstability shaft coupled to the adjustment device, wherein the fineadjustment mechanism is configured to selectively move the handle andthe shaft relative to the adjustment device and the outer stabilityshaft.
 2. The delivery device of claim 1, wherein the fine adjustmentmechanism includes a toothed wheel that is coupled to teeth on thehandle.
 3. The delivery device of claim 2, wherein the toothed wheel isoriented relative to a longitudinal axis of the adjustment device andthe handle such that the toothed wheel rotates parallel to thelongitudinal axis to move the handle and the shaft.
 4. The deliverydevice of claim 2, further comprising a second toothed wheel disposedbetween the toothed wheel and the teeth on the handle, wherein thetoothed wheel is coupled to the second toothed wheel and the secondtoothed wheel is coupled to the teeth on the handle.
 5. The deliverydevice of claim 1, wherein the outer stability shaft is configured toisolate the sheath from a separate introducer valve component throughwhich the delivery device is inserted into a patient.
 6. The deliverydevice of claim 1, wherein the sheath comprises a distal capsule and aproximal shaft, wherein the proximal shaft is attached to an actuatormechanism of the handle, and wherein the distal capsule is configured tocompressively constrain the stented prosthetic heart valve.
 7. Thedelivery device of claim 6, wherein an outer diameter of the capsule isgreater than an outer diameter of the proximal shaft, the proximal shaftbeing affixed to the capsule at a connection point, and further whereinin a delivery configuration, the connection point is distal of thedistal end of the stability shaft by a distance in the range of 3-13 cm.8. The delivery device of claim 6, wherein an outer diameter of thecapsule is greater than an outer diameter of the proximal shaft, thecapsule being affixed to the proximal shaft at a connection point, andfurther wherein in a deployed configuration, the connection point isdistal of the distal end of the stability shaft.
 9. The delivery deviceof claim 1, wherein the adjustment mechanism is configured toselectively move the handle and the sheath relative to the adjustmentdevice and the outer stability shaft a distance in the range of 10-40mm.
 10. A method for restoring a defective heart valve in a patient, themethod comprising the steps of: manipulating a delivery device loadedwith a radially expandable prosthetic heart valve in a radiallycompressed configuration, the prosthetic heart valve having a stentframe to which a valve structure is attached, the delivery deviceincluding a delivery sheath constraining the prosthetic heart valve inthe radially compressed configuration, an outer stability shaftcoaxially received over the delivery sheath and terminating proximal ofthe prosthetic heart valve with the delivery device in a deliveryconfiguration, a handle including a housing and an actuator mechanismcoupled to the delivery sheath, and an adjustment device coupled to thehandle, to guide the prosthetic heart valve through the patient'svasculature and into the defective heart valve by moving the handle,which correspondingly moves the adjustment device, delivery sheath, andstability shaft; finely adjusting the location of the prosthetic heartvalve by manipulating the fine adjustment mechanism on the adjustmentdevice, wherein manipulating the fine adjustment mechanism causes thehandle and the delivery sheath to move relative to the adjustment deviceand the outer stability shaft; and withdrawing the delivery sheath fromthe prosthetic heart valve by actuating the actuator mechanism such thatthe delivery sheath slides relative to the outer stability shaft and thehandle to release the prosthetic heart valve from the delivery sheathsuch that the prosthetic heart valve self-expands into engagement withthe native heart valve.
 11. The method of claim 10, wherein the step ofwithdrawing the delivery sheath includes the outer stability shaftisolating the delivery sheath from an introducer valve.
 12. The methodof claim 10, wherein the fine adjustment mechanism includes a toothedwheel that is coupled to teeth on the handle, wherein the step of finelyadjusting the location of the prosthetic heart valve comprises rotatingthe toothed wheel to move the handle and the delivery sheath attached tothe handle.
 13. The method of claim 12, wherein the toothed wheel isoriented relative to the longitudinal axis of the adjustment device andthe handle such that the toothed wheel rotates parallel to thelongitudinal axis to move the handle and the delivery sheath.
 14. Themethod of claim 12, further comprising a second toothed wheel disposedbetween the toothed wheel and the teeth on the handle, such that thestep of adjusting the fine adjustment mechanism comprises rotating thetoothed wheel which rotates the second toothed wheel, which moves thehandle via the teeth on the handle.
 15. The method of claim 10, whereinthe delivery device further includes an inner shaft disposed within thedelivery sheath such that the prosthetic heart valve is disposed betweenthe inner shaft and the delivery sheath in the delivery configuration,wherein during the step of finely adjusting the location of theprosthetic heart valve the inner shaft moves with the handle and thedeliver sheath relative to the adjustment device and the outer stabilityshaft.
 16. The method of claim 15, wherein during the step ofwithdrawing the delivery sheath, the delivery sheath slides relative tothe inner shaft.